BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L

    K Number: K022948 · Decision Nov 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    8
    Review Days
    60

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
    K Number
    K022948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Action Industries, Inc.
    Date Received
    September 5, 2002
    Decision Date
    November 4, 2002
    Product Code
    HIB
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIB Speculum, Vaginal, Nonmetal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HIB), ordered by most recent decision date.

    JFord Speculum Sleeve™

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BRELLA-SPEC(TM) VAGINAL SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IOB DISPOSABLE SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CLEARSPEC SINGLE USE VAGINAL SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPECULUM, VAGINAL, NONMETAL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KOLPLUX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Medical Action Industries, Inc.

    K Number Device Name
    K042526 DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
    K042527 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    K946019 SURGICLA INSTRUMENT KIT
    K923846 BURN DRESSING
    K884826 GAUZE SPONGE
    K810685 SUTURE REMOVAL KIT
    K810184 LAPAROTOMY SPONGE